QuikFix External Fixator: Knee-Spanning Pack

Q: What is the product code of K260112?

The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.

FDA 510(k) K260112 · Stabiliz Orthopaedics, Inc.

Substantially Equivalent

510(k) numberK260112

Submission

Device name: QuikFix External Fixator: Knee-Spanning Pack
Applicant: Stabiliz Orthopaedics, Inc.
Exton, PA, US
Received: January 14, 2026
Decision date: March 23, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3030
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code KTT

510(k)	Device	Applicant	Decision
K254087	MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction SystemKTT · Traditional	Synthes (USA) Products, LLC	06/11/2026SE
K260900	DYNEX® External Fixation SystemsKTT · Special	Vilex, LLC	04/17/2026SE
K253291	Excelsior SystemKTT · Traditional	Blue Ocean Global	01/20/2026SE
K253613	Monkey Rings External Ring Fixation SystemKTT · Special	Paragon 28, Inc.	12/19/2025SE
K253202	Hoffmann LRF SystemKTT · Traditional	Stryker GmbH	12/19/2025SE
K252555	Medusa Orthopedics Boa External Fixation SystemKTT · Traditional	Medusa Orthopedics, LLC	11/25/2025SE
K252625	The Response Ortho Smart Fixator - Hexapod SystemKTT · Traditional	Response Ortho Solutions, LLC	11/20/2025SE
K252106	External Fixation Mini Rail SystemKTT · Traditional	Paragon 28, Inc.	09/30/2025SE
K251862	External Fixation Bone DistractorKTT · Traditional	Paragon 28, Inc.	08/11/2025SE
K250472	SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)KTT · Traditional	Amdt Holdings, Inc.	08/08/2025SE

More from Amdt Holdings, Inc.

510(k)	Device	Decision
K230053	SimpliFix Hip SystemHWC · Traditional	04/19/2023SE
K130731	Stabiliz Fixation System - SPL Locking ScrewHRS · Traditional	07/19/2013SE
K120651	Stabiliz Fixation SystemHRS · Traditional	11/27/2012SE

Questions and answers

When was QuikFix External Fixator: Knee-Spanning Pack cleared by the FDA?

QuikFix External Fixator: Knee-Spanning Pack (K260112) received a 510(k) decision of Substantially Equivalent on March 23, 2026, 68 days after the submission was received.

What is the product code of K260112?

The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.